AIA-PACK TT3 ASSAY— 510(k) K936229

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K936229 for AIA-PACK TT3 ASSAY, Substantially Equivalent on 1994-07-14. Applicant: Tosoh Medics, Inc..

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1993-12-29
Decision date: 1994-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.